SnapSBO - Small Bowel Obstruction Snapshot Audit

NCT05843097 | Completed DMC

• 1 other identifier: ESTESSnapSBO202324
• Study Type: observational
• Target: 1,900
• Locations: 1 country
• Sites: 1

Brief Summary

Small bowel obstruction (SBO) and its complications are frequently seen in patients admitted through the Emergency Departments of all acute care hospitals2. There is variation in the optimal use of imaging, the appropriate timing and duration of non-operative management attempts, anti-microbial therapies, and the criteria for surgical management, which results in heterogeneity in approaches and outcomes across international clinical centers. The expected number of SBO cases in most clinical centers is predictable, enabling a suitably-sized cohort of patients to be gathered in the snapshot audit. This 'ESTES snapshot audit' -a prospective observational cohort study- has a dual purpose. Firstly, as an epidemiological study, it aims to uncover the burden of disease. Secondly, it aims to demonstrate current strategies employed to diagnose and treat these patients. These twin aims will serve to provide a 'snapshot' of current practice, but will also be hypothesis-generating while providing a rich source of patient-level data to allow further analysis of the particular clinical questions.

Conditions

Small Bowel Obstruction

Keywords

diagnosis; management; guidelines; outcomes

Outcome Measures

Primary Outcomes (2)

• Incidence of Small Bowel Obstruction, by etiology

  This study aims to quantify (as an integer, n) the etiologies of small bowel obstruction (adhesions, hernias, malignancy and other causes)

  6 months

• Time to Surgical Treatment of Small Bowel Obstruction vs Outcomes

  Time (hours) from hospital admission to Surgical Treatment of Small Bowel Obstruction vs Outcomes

  6 months

Secondary Outcomes (3)

• Complications related to operative or non-operative management of small bowel obstruction

  6 months from hospital admission

• Adherence to evidence-based guidelines vs outcomes

  6 months from hospital admission

• Patient-related Outcome Metrics for Surgical vs Non-operative management

  At first post-discharge clinic visit, anticipated within 6 months of admission

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients (≥16 years of age) admitted for mechanical small bowel obstruction.

You may qualify if:

• Adult patients (≥16 years of age) admitted for mechanical small bowel obstruction. Example etiologies which should be included:
• Adhesions.
• Hernias with bowel compromise (incisional/parastomal, ventral, inguinal, femoral, obturator, internal).
• Malignancy (primary: lymphoma, carcinoid, GIST, adenocarcinoma/metastatic disease: colon, ovarian, gastric, pancreatic, melanoma and others).
• Enteroliths/gallstones/bezoars/foreign bodies
• Radiation.
• Inflammation (Crohn's disease, mesenteric adenitis, appendicitis, diverticulitis, tuberculosis, actinomycosis, ascariasis).
• Congenital (malrotation, duplication cysts).
• Trauma (hematomas, ischemic strictures).

You may not qualify if:

• Functional small bowel obstruction (dysmotility or adynamic ileus secondary to abdominal operations, peritonitis, trauma or medications).

Sponsors & Collaborators

• European Society for Trauma and Emergency Surgery: lead

Study Sites (1)

Hospital Universitario Virgen del Rocio

Seville, Andalusia, 41013, Spain

Location

Related Publications (1)

• Bass GA, Kaplan LJ, Ryan EJ, Cao Y, Lane-Fall M, Duffy CC, Vail EA, Mohseni S. The snapshot audit methodology: design, implementation and analysis of prospective observational cohort studies in surgery. Eur J Trauma Emerg Surg. 2023 Feb;49(1):5-15. doi: 10.1007/s00068-022-02045-3. Epub 2022 Jul 15.

  PMID: 35840703 BACKGROUND

MeSH Terms

Conditions

Disease

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Isidro Martínez Casas, MD PhD

  Hospital Universitario Virgen del Rocio

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chair, SnapSBO Steering Group

Study Record Dates

• First Submitted: March 10, 2023
• First Posted: May 6, 2023
• Study Start: November 1, 2023
• Primary Completion: September 1, 2024
• Study Completion: September 1, 2024
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: After study main conclusions are published
• Access Criteria: Being one of study participating centers investigators

Locations

ES (1)